in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis;

for the prolongation of the remission period between acute attacks of ulcerative colitis;

in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs);

in the treatment of pediatric patients with polyarticular-course1 juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal antiinflammatory drugs.

INSTRUCTIONS

Use Azulfidine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Azulfidine by mouth after meals.Take Azulfidine with a full glass of water (8 oz/240 mL).Drinking extra fluids while you are taking Azulfidine is recommended. Check with your doctor for instructions.Space your doses evenly over the hours you are awake. If possible, try not to space your doses more than 8 hours apart.Take Azulfidine on a regular schedule to get the most benefit from it.Continue to take Azulfidine even if you feel well. Do not miss any doses.If you miss a dose of Azulfidine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

DOSAGE

Use Azulfidine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Azulfidine by mouth after meals.Take Azulfidine with a full glass of water (8 oz/240 mL).Drinking extra fluids while you are taking Azulfidine is recommended. Check with your doctor for instructions.Space your doses evenly over the hours you are awake. If possible, try not to space your doses more than 8 hours apart.Take Azulfidine on a regular schedule to get the most benefit from it.Continue to take Azulfidine even if you feel well. Do not miss any doses.If you miss a dose of Azulfidine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

DOSAGE

The dosage of Azulfidine should be adjusted to each individual's response and tolerance.

Patients should be instructed to take Azulfidine in evenly divided doses, preferably after meals, and to swallow the tablets whole.

Initial Therapy

Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. It may be advisable to initiate therapy with a lower dosage, e.g., 1 to 2 g daily, to reduce possible gastrointestinal intolerance. If daily doses exceeding 4 g are required to achieve the desired therapeutic effect, the increased risk of toxicity should be kept in mind.

Children, six years of age and older: 40 to 60 mg/kg of body weight in each 24-hour period, divided into 3 to 6 doses.

STORAGE

Store Azulfidine at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Azulfidine out of the reach of children and away from pets.

SAFETY INFORMATION

Some medical conditions may interact with Azulfidine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substancesif you have liver or kidney problems, asthma, severe allergies, blood problems (eg, anemia, low white blood cell levels), or rheumatoid arthritis

if you have glucose-6-phosphate dehydrogenase deficiency

if you have an infection (eg, strep throat)

Some MEDICINES MAY INTERACT with Azulfidine. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin) or methotrexate because the risk of their side effects may be increased by Azulfidine

Beta-blockers (eg, propranolol), digoxin, or folic acid because their effectiveness may be decreased by Azulfidine

Methenamine because the risk of crystals in the urine may be increased

This may not be a complete list of all interactions that may occur.

Azulfidine may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Azulfidine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.Azulfidine may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Azulfidine. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.Azulfidine may discolor the urine or skin an orange-yellow color. This is normal and not a cause for concern.Contact your doctor if you develop sore throat, fever, unusually pale skin, dark urine, pale stools, persistent stomach pain or loss of appetite, yellowing of the skin or eyes, or unusual bruising or bleeding. Contact your doctor if you have yellowing of the skin along with dark urine, pale stools, or persistent stomach pain or loss of appetite. These could be signs of a serious side effect.Some men taking Azulfidine have developed a decreased number of sperm and infertility. These effects usually went away after Azulfidine was stopped. Discuss any questions or concerns with your doctor.Lab tests, including liver function, kidney function, complete blood cell counts, or urine tests, may be performed while you use Azulfidine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.Use Azulfidine with caution in the ELDERLY; they may be more sensitive to its effects.Azulfidine should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.Use Azulfidine with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Azulfidine while you are pregnant. Azulfidine is found in breast milk. If you are or will be breast-feeding while you use Azulfidine, check with your doctor. Discuss any possible risks to your baby.

SIDE EFFECTS

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; loss of appetite; mild stomach upset or pain; nausea; vomiting.Seek medical attention right away if any of these SEVERE side effects occur: